May 17, 2020

Will J&J Win the Race to Create an Ebola Virus Vaccine?

Johnson & Johnson
3 min
The Ebola virus has killed over 8,000 people in West Africa, according to the World Health Organization.
Johnson & Johnson (J&J) announced on Tuesday, Jan. 6 that it has begun testing its Ebola virus vaccine on humans and will have more than 400,000...

Johnson & Johnson (J&J) announced on Tuesday, Jan. 6 that it has begun testing its Ebola virus vaccine on humans and will have more than 400,000 doses available by April.

The pharma giant started a trial of its experimental Ebola vaccine in the U.K. and the first volunteers at the University of Oxford have received an initial dose. The trial aims to recruit 72 people by the end of the month, according to the New Brunswick.

Additional tests are planned for the U.S., Kenya, Uganda and Tanzania.

The vaccine uses a booster from Denmark’s Bavarian Nordic and is now the third shot to enter human testing. The commencement of this Phase I testing marks further progress in the race to develop a vaccine against the disease that has claimed the lives of more than 8,000 people in West Africa since last year and affected more than 20,000 people, according to the World Health Organization.

[READ MORE] Ebola Breakthrough: Has Germany Found a Cure With This Experimental Drug?

As many as 12 million doses of vaccine may be needed to bring the outbreak under control, J&J said, citing the London School of Hygiene and Tropical Medicine. Previously, the company aimed to manufacture more than 1 million by the end of 2015, with 250,000 available for clinical trials by May.

Just how much Ebola vaccine will be needed depends on how quickly the epidemic in Liberia, Sierra Leone and Guinea is brought under control and declines. Currently, experts project demand at anywhere between 100,000 and 12 million doses.

“As long as there are still Ebola patients, there is the risk that it will continue to go around the region,” Paul Stoffels, J&J's chief scientific officer, told reporters. “Does it come too late? That’s going to be answered when we are there. I don't think so.”

Phase I Trials

Phase I trials of the vaccine are intended to test primarily for safety but may also indicate whether vaccines produce a positive immune response.

In total, roughly 300 subjects will be involved in Phase I testing after which J&J hopes to rapidly move into larger studies, with final-stage Phase III trials planned for the second quarter of 2015.

The vaccine uses a so-called “prime-boost” approach of giving a first shot to stimulate the immune system, followed by a second booster a few weeks later.

“What we are doing with prime-boost is going for maximal protection, as well as long-term protection,” said Stoffels.

[READ MORE] TOP 10: Innovative Pharma Companies to Watch in 2015

Tests have already begun to show that the vaccine can be stored in a normal fridge for several months rather than needing special freezing, which is difficult to do in rural Africa.

The Cost of a Vaccine

Although it is too early to say how much a vaccine might cost, the GAVI global vaccines alliance announced last month it was committing up to $390 million to buy Ebola shots.

J&J said in October it was committing as much as $200 million to accelerate and expand production of the vaccine, and buy new shares in Bavarian Nordic. The investment has allowed Bavarian Nordic “to work at an unprecedented pace,” Paul Chaplin, the company’s CEO, said in a separate statement.

Shares in Bavarian Nordic, which received investment from J&J last year to accelerate production, rose 3.9 percent to their highest level in four years.

Human testing is already under way for two other vaccines, one by NewLink Genetics Corp. (NLNK) and Merck & Co. and the other by GlaxoSmithKline Plc. (GSK). Both involve a single shot, though Stoffels said he’s confident that people who receive the first J&J shot will return for the second.

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Apr 30, 2021

The challenges to vaccine distribution affecting everyone

Jonathan Colehower
5 min
The challenges to vaccine distribution affecting everyone
Jonathan Colehower, CEO at CargoChain, describes the COVID-19 vaccine distribution challenges impacting every country, organisation and individual...

While it is comforting to know that vaccines against COVID-19 are showing remarkable efficacy, the world still faces intractable challenges with vaccine distribution. Specifically, the sheer number of vaccines required and the complexity of global supply chains are sure to present problems we have neither experienced nor even imagined. 

Current projections estimate that we could need 12-15 billion doses of vaccine, but the largest vaccine manufacturers produce less than half this volume in a year. To understand the scale of the problem, imagine stacking one billion pennies – you would have a stack that is 950 miles high. Now, think of that times ten. This is a massive problem that one nation can’t solve alone.  

Production capacity 

Even if we have a vaccine – can we make enough? Based on current projections, Pfizer expects to produce up to 1.3 billion doses this year. Moderna is working to expand its capacity to one billion units this year. Serum Institute of India, the world’s largest vaccine producer, is likely to produce 60% of the 3 billion doses committed by AstraZeneca, Johnson & Johnson and Sanofi. This leaves us about 7 billion doses short. 

Expanding vaccine production for most regions in the world is complicated and time-consuming. Unlike many traditional manufacturing operations that can expand relatively quickly and with limited regulation, pharmaceutical production must meet current good manufacturing practice (CGMP) guidelines. So, not only does it take time to transition from R&D to commercial manufacturing, but it could also take an additional six months to achieve CGMP certification. 

The problem becomes even more complex when considering the co-products required. Glass vials and syringes are just two of the most essential co-products needed to produce a vaccine. Last year, before COVID-19, global demand for glass vials was 12 billion. Even if it is safe to dispense ten doses per vial, there is certain to be significant pressure on world supply of the materials needed to package and distribute a vaccine.

It is imperative drug manufacturers and their raw material suppliers have clear visibility of production plans and raw material availability if there is any hope of optimizing scarce resources and maximising production yield.

Distribution requirements

It is widely known by now that temperature is a critical factor for the COVID-19 vaccine. Even the regions with the most developed logistics infrastructures and resources needed to support a cold-chain network are sure to struggle with distribution.

For the United States alone, State and local health agencies have determined distribution costs will exceed $8.4 billion, including $3 billion for workforce recruitment and training; $1.2 billion for cold-chain, $1 billion vaccination sites and $0.5 billion IT upgrades.  

The complexity of the problem increases further when considering countries such as India that do not have cold-chain logistics networks that meet vaccine requirements. Despite India’s network of 28,000 cold-chain units, none are capable of transporting vaccines below -25°Celsius. While India’s Serum Institute has licensed to manufacture AstraZeneca’s vaccine, which can reportedly be stored in standard refrigerated environments, even a regular vaccine cold chain poses major challenges.

Furthermore, security will undoubtedly become a significant concern that global authorities must address with a coordinated solution. According to the Pharmaceutical Security Institute, theft and counterfeiting of pharmaceutical products rose nearly 70% over the past five years. As with any valuable and scarce product, counterfeits will emerge. Suppliers and producers are actively working on innovative approaches to limit black-market interference. Corning, for example, is equipping vials with black-light verification to curb counterfeiting.

Clearly, this is a global problem that will require an unprecedented level of collaboration and coordination.

Disconnected information systems 

While it is unreasonable to expect every country around the world will suddenly adopt a standard technology that would provide immediate, accurate and available information for everyone, it is not unreasonable to think that we can align on a standard taxonomy that can serve as a Rosetta Stone for collaboration. 

A shared view of the situation (inventory, raw materials, delivery, defects) will provide every nation with the necessary information to make life-saving decisions, such as resource pooling, stock allocations and population coverage.

By allowing one central authority, such as the World Health Organization, to organize and align global leaders to a single collaboration standard, such as GS1, and a standard sharing protocol, such as DSCSA, then every supply chain participant will have the ability to predict, plan and execute in a way that maximises global health.

Political influence and social equality 

As if we don’t have enough stress and churn in today’s geopolitical environment, we must now include the challenge of “vaccine nationalism.” While this might not appear to be a supply chain problem, per se, it is a critical challenge that will hinge on supply chain capabilities.

In response to the critical supply issues the world experienced with SARS-CoV-2, the World Health Organization, Gavi, the Vaccine Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) formed Covax: a coalition dedicated to equitable distribution of 2 billion doses of approved vaccines to its 172 member countries. Covax is currently facilitating a purchasing pool and has made commitments to buy massive quantities of approved vaccines when they become available.  

However, several political powerhouse countries, such as the United States and Russia, are not participating. Instead, they are striking bilateral deals with drug manufacturers – essentially, competing with the rest of the world to secure a national supply. Allocating scarce resources is never easy, but when availability could mean the difference between life and death, it becomes almost impossible.

Global production, distribution and social equality present dependent yet conflicting realities that will demand global supply chains provide complete transparency and an immutable chain of custody imperative to vaccine distribution. 

The technology is available today – we just need to use it. We have the ability to track every batch, pallet, box, vile and dose along the supply chain. We have the ability to know with absolute certainty that the vaccine is approved, where and when it was manufactured, how it was handled and whether it was compromised at any point in the supply chain. Modern blockchain technologies should be applied so that every nation, institution, regulator, doctor and patient can have confidence in knowing that they are making an impact in eradicating COVID-19.

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